Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT.
Study Overview
Brief Summary
The objective of the clinical trial is to evaluate the SPACE 360 Delivery System using SPACE CpsXL Bone Cement compared to standard vertebroplasty in the treatment of pathological fractures of the spine caused by metastatic tumors of the spine, myeloma, or lymphoma. Up to a total of three levels per patient may be included or five levels for multiple myeloma. The control group will be standard vertebroplasty.
Detailed Description
The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT. Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and females between 18 and 85 years of age
- •Pain at one to three levels, or five for multiple myeloma (pain on palpation/percussion over fractured vertebral body) requiring treatment
- •Spinal metastasis (except renal cell), myeloma, or lymphoma of the spine
- •Pathological fracture(s), T5-L5, with bone marrow edema imaged by magnetic resonance imaging (MRI)
- •Visual Analog Scale (VAS) for pain of > 4 on a scale of 0 to 10
- •Oswestry score of at least a moderate disability (21-40%)
- •No major surgery to the spine planned for at least 1 month following enrollment - Defined as a procedure the magnitude of a laminectomy or more
- •Life expectancy of > 6 months.
- •Patient has sufficient mental capacity to comply with the protocol requirements
- •Availability for all study visits and phone calls
- •Understands the potential risks and benefits of participating in the study and is willing to provide written informed consent
- •Pathological vertebral fracture with 20-70% compression (compared to adjacent normal vertebral body)
- •Fracture age < 6 months
- •Signal on MRI consistent with non-healed fracture
- •Female subjects must either be no longer capable of reproduction or taking acceptable measures to prevent pregnancy during the study
- •Subject must be willing and able to comply with specified follow-up evaluations
Exclusion Criteria
- •Primary tumors other than plasmacytoma
- •Renal cell tumors
- •More than 80% compression of the vertebrae
- •Level(s) above T7 to treat
- •Fractures due osteoporosis
- •Burst fracture
- •Pedicle fracture
- •Neurological deficit associated with the fracture
- •Kyphosis > 30°
- •Translation > 4 mm
- •Instability of posterior wall with symptomatic displacement of fragment into spinal canal or significant canal compromise
- •Intercostal nerve compression
- •Active systemic or local infection at the level(s) to be treated
- •Uncontrolled coagulopathy
- •Cannot temporarily discontinue anticoagulation therapy
- •Known allergy to device materials / PMMA
- •Radiculopathy
- •Cord compression or canal compromise requiring surgery for decompression
- •High energy trauma
- •Severe cardiopulmonary deficiencies - Defined as not being able to tolerate general anesthesia (although the likelihood is local anesthesia will be used)
- •Vertebra plana defined as vertebral body height of 20% or less compared to the nearest normal level
- •Disabling back pain secondary to another cause that may interfere with accurate data collection
- •Subjects who are known to be pregnant (pregnancy test required within 10 days of treatment) or lactating
- •Females capable of reproduction and will not take acceptable measures to prevent reproduction during the study
- •Subjects who test positive for HIV
- •Currently enrolled in another investigational device trial (IDE) that has not completed the protocol required primary follow-up period (excludes 15 year follow-up of gene therapy trials)
- •Lesions involving the pedicle
- •Platelet count of < 50,000
Arms & Interventions
2
Subjects randomized to the control arm of the study will have a standard vertebroplasty with any FDA-approved bone cement done in accordance with the usual method employed by the treating physician.
Intervention: standard vertebroplasty (Device)
1
Subjects randomized to the experimental arm of the study will have a vertebroplasty with the SPACE CpsXL Bone cement (FDA-approved) and SPACE 360 Delivery System (FDA-approved).
Intervention: SPACE CpsXL Bone Cement and SPACE 360 Delivery System (Device)
Outcomes
Primary Outcomes
The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT.
Time Frame: 3 years
Secondary Outcomes
- Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index).(3 years)